Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

July 4, 2012 updated by: Maxim Mazanikov, Helsinki University Central Hospital

Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study

Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Deep sedation with propofol has been suggested necessary for successful performance of endoscopic retrograde cholangiopancreatography (ERCP).Airway obstruction, hypoventilation and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.As a result of frequent hypoxemia events, deep sedation is associated with increased morbidity and mortality.Careful monitoring of vital signs and involving of anesthesia-trained personal are recommended for deeply sedated patients.Self-administration of propofol by the patient him- or herself (patient-controlled sedation, PCS)could be a safer way to use propofol without the presence of an anesthesiologist. In comparison to the anesthesiologists managed deep sedation the main advantages of PCS are reduced consumption of anesthetics and faster recovery.A combination of propofol and different opioids is widely used for PCS however, it is not known which opioid would be the most suitable one. Remifentanil is a potent opioid with ultra short duration of action and usually administered as a constant infusion. The elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of remifentanil. Both opioids have been evaluated previously in PCS but comparative studies are lacking. This study was carried out in order to compare remifentanil and alfentanil in PCS during ERCP in terms of propofol consumption, sedation levels, endoscopist´s and patient's satisfaction. The investigators also sought information about frequency of sedation related complications associated with the different opioids.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective ERCP patients

Exclusion Criteria:

  • allergy to propofol or opioid analgesics, drug addiction, inability to co-operate, ASA class greater than 3, or patient's refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: remifentanil
sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml
Drug: remifentanil
Remifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min.
Other Names:
  • Ultiva
ACTIVE_COMPARATOR: alfentanil 0.04 mg/ml
sedative mixture for PCS consisting of propofol10 mg/ml 20 ml,alfentanil 0.5 mg/ml 2 ml, NaCL 9 mg/ml 3 ml
Drug: alfentanil
Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.
Other Names:
  • Alfenta
  • Rapifen
ACTIVE_COMPARATOR: alfentanil 0.08 mg/ml
sedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml
Drug: alfentanil
Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.
Other Names:
  • Alfenta
  • Rapifen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
consumption of propofol and opioid
Time Frame: one day
one day
vital signs
Time Frame: one day
Heart rate (HR), electrocardiogram (ECG), breathing rate, peripheral oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) constant monitoring. Noninvasive blood pressure (NIBP)measuring at 5 min intervals.
one day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sedation levels
Time Frame: one day
Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score
one day
pain intensity
Time Frame: one day
Numeric range scale
one day
patient´s and endoscopist´s satisfaction with sedation
Time Frame: one day
one day
incidence of nausea
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Reino Pöyhiä, MD,PhD, Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
  • Principal Investigator: Harri Mustonen, DSc, Helsinki University Central Hospital, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • a002c
  • 2009-012398-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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